Regulatory Project Manager

GSK

Regulatory Project Manager overseeing CMC submissions in the Vaccine area at GSK. Leading initiatives to ensure timely delivery and compliance with regulatory standards.

Posted 4/17/2026full-timePoznan • 🇵🇱 PolandMid-LevelSenior💰 PLN 183,750 - PLN 306,250 per yearWebsite

About the role

Key responsibilities & impact

Take ownership for multiple complex CMC regulatory submissions, including planning, coordination and execution, to support applications for marketing authorizations, lifecycle activities and maintenance of registered products across Vaccines portfolio, in accordance with the applicable regulatory and scientific standards.
Manage multiple project assignments simultaneously, including CMC variations and handling Health Authority Questions (HAQs) for Finished Products, Intermediates, and Active Pharmaceutical Ingredients for Vaccines products (i.e. largely involving updates to the CTD Module 3, Quality section of the dossiers).
Identify risks associated with submission data and information package; and support the development of mitigation strategies.
Collaborate closely with cross-functional teams, such as Global Regulatory Lead’s team, Global Supply Chain (GSC), Quality Assurance (QA), Local Operating Companies (LOCs), and third Parties to build regulatory CMC submissions and maintain strong relationships, including with senior stakeholders.
Identify improvement opportunities for CMC Regulatory processes, policies, instructions and systems, developing and implementing simplified working practices and procedures to enhance efficiency and quality.
Serve as Subject Matter Expert (SME) for CMC Regulatory Affairs, mentoring and guiding team members, while sharing best practices to build capability and knowledge within the CMC Regulatory teams and other impacted functions.

Requirements

What you’ll need

Advanced degree (Master's or above) in Pharmacy, Biotechnology, Biology, Chemistry/Biochemistry or other closely related medical/life science field.
Strong experience in CMC Regulatory Affairs within pharmaceutical industry or research organization.
Extensive expertise in regulatory strategy planning, dossier preparation (CTD Module 1-3), technical dossier review and in all associated CMC regulatory aspects.
Sound understanding of the pharmaceutical industry, drug development environment, regulatory processes and ICH guidelines and requirements, including EU regulatory framework.
Exceptional flexibility, analytical thinking and growth mindset.
Excellent interpersonal skills; including clear and effective written and verbal communication, and the ability to build strong relationships across a diverse, large organization.
English writing skills.
Excellent organizational skills, ability to handle multiple tasks, prioritize effectively and deliver high quality output under imposed deadlines, with a strong attention to detail (with emphasis on accuracy and completeness).

Benefits

Comp & perks

private healthcare
additional paid days off
life insurance
private pension plan
fully paid parental leave & care of family member leave

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

CMC regulatory submissionsregulatory strategy planningdossier preparationCTD Module 1-3technical dossier reviewregulatory processesICH guidelinesEU regulatory frameworkrisk identificationmitigation strategies

Soft Skills

analytical thinkingflexibilitygrowth mindsetinterpersonal skillswritten communicationverbal communicationrelationship buildingorganizational skillsprioritizationattention to detail

Certifications

advanced degreeMaster's degreePhD